There are many situations in which it is necessary to perform an ileostomy, colostomy, or other similar enterostomy on a patient. Typically, an enterostomy involves externalizing an internal vessel, such as the duodenum, jejunum, ileum, colon, or ureter. The commonly practiced enterostomy involves severing the particular vessel which is to be externalized and then suturing the wall of the vessel to an opening which has been formed on the surface of the body. The vessel which is extended out of the patient's body is generally referred to medically as the "stoma". Typically, the opening is formed through the patient's abdomen.
Following the typical enterostomy an appliance is attached to the patient. The typical appliance comprises an ostomy bag or collection pouch, a connecting ring and faceplate which is glued to the skin surrounding the stoma. This serves to collect waste matter as it is discharged by the externalized vessel. An appliance, according to medical dictionaries, is a device affixed to or implanted in the body and designed to take the place of or perform the function of a missing body part. Often an appliance of a patient exchanges a part of the body for a functional device. There are two classes of appliances: permanent and temporary. Temporary appliances are disposable pouches or wafers, used postoperatively until the stoma has sufficiently healed and a permanent appliance has been selected. In general, permanent appliances are those which can be cleaned and reused. A permanent faceplate may accommodate either a temporary or a permanent pouch. Appliances are manufactured in various sizes to accommodate anatomic variances of patients--newborn, pediatric, regular, and extra large sizes.
Over the past 20 years, much energy has been spent on and vast improvements have been made in ostomy appliances. At present, the variety of equipment available to ostomy patients is bewildering to all but the few experts who take a special interest in this field. With very few exceptions, ostomy patients today use an adherent appliance which in essence is composed of a flat faceplate adhered tightly to the peristomal skin and through the center of which the stoma projects into a pouch that collects the excrements.
The patient who undergoes an ostomy operation has no control over the passage of body wasted materials, liquids, or gases through the intestine or other vessel to the stoma. In the past, pads or adhesively secured receiving ports or faceplates have been used together with a collection receptacle, such as an ostomy bag, and have been taped or adhesively secured over the opening or attached to the stoma by a belt around the body in order to cover the stoma and thereby collect the escape of body waste, liquids, and gases. The known, currently used ostomy devices are inefficient, ineffective, and often lead to embarrassing situations.
The pouches commonly have openings or mouths that are adhesively secured to the skin or connected around the stoma via the faceplate having an ostomy ring. The pouches must be periodically removed and emptied after body excrements have been collected therein. It is important that the adhesive seal between the mouth of the bag and the faceplate and the skin surrounding the stoma be maintained airtight to prevent the escape of embarrassing odors or the leakage of body excrement. All too often with currently available appliances, the patient may suffer painful irritation and serious infection when the area between the adhesive seal and the skin breaks down and comes in contact with bodily excrement.
Typical ports, or faceplates, require the user to adhere the underside of the plate to the skin surrounding the stoma. Although faceplates come in numerous styles and materials, they are not able to ensure a completely tight, leak-proof seal around the stoma. Additionally, it is common that the ostomy patient will suffer pain or great discomfort when attaching or reattaching the pouch, because it is normally necessary to apply some force to engage or disengage the coupling elements. Further, ostomy patients are normally required to remove the faceplate and clean the area every three to five days. The procedure involved in removing and reattaching the faceplate is time consuming and can cause serious skin irritations, which can then lead to serious infections.
The currently available ostomy appliances include a number of accessories that become costly and tend to complicate the ostomy patient's life. These accessories include: Stomahesive, reliaseal, and karaya disks used as gaskets. Karaya gum powder or paste is used as a protective base, allowing the skin to heal. A karaya gum washer may be stretched or cut to fit snugly around the stoma. Very thin, double-faced adhesive disks are used to adhere the faceplate and appliance to the skin and are often used instead of cement. Solvents may be used to dissolve cement and adhesives and are necessary for removing the appliance. A noncaustic oil base solvent is available for those with tender skin. Telfa.RTM. may be used when the skin becomes irritated. Telfa.RTM. is a sterile, nonadhering dressing that allows excoriated skin to heal without further damage. Micropore, a paper tape, is a nonallergenic tape for those who are unable to use adhesive tape. Stoma bibs made of diaper cloth or cotton flannel fit under the plastic pouch to absorb perspiration and keep the appliance from contacting the skin. O-rings, made of covered elastic thread, may be stretched slightly to fit around the disk to secure the pouch. Rubber rings or plastic valve sets may be utilized as pouch closures.
Currently an ostomy patient must not only learn to use all the accessories and deal with the inconveniences and uncomfortable situations involved in having an ostomy bag appliance, but must continually, almost obsessively, deal with the cleaning, changing and administering of the appliance. Further, the currently available faceplates not only cause irritation to the skin upon being changed or removed, but as the faceplate loosens from the skin during normal human activity, fecal matter can contact and collect on the irritated skin area and cause serious infection and further discomfort to the patient. When skin irritations or infections do result, the patient is often required to expend additional time and money to treat the problem, which may require expensive antibiotics or even admittance to a hospital.
The use of adhesively secured faceplates can create great discomfort and even dangerous infections to the ostomy patient. Accordingly, not only does the patient have to deal with the stresses of maintaining the ostomy device, but must also be concerned with embarrassing and harmful leakage of the excrement between the stoma and the faceplate. Typically, these faceplates work effectively for a limited time period. After the user has repeatedly attached, and removed the pouch from the faceplate, the faceplate may begin to separate from the skin, thereby allowing excrement to leak. In attempting to prevent the leakage, patients have been known to use duct tape, dangerous adhesive solutions, or other less than satisfactory ways to solve the problem of leakage from between the faceplate and the patient's skin. Such homemade remedies are only temporary solutions and often lead to even more serious infections and discomfort.
For every ostomy patient, there exists the everpresent possibility of skin irritation. The most common cause of skin problems to the ostomy patient is leakage under the faceplate of the appliance. Whenever excrement comes into direct contact with the skin, irritation develops and very soon excoriation and intense inflammation supervenes. skin damage may arise from too frequent changing of the appliance, excessive use of adhesive remover, or too vigorous scrubbing or drying of the peristomal area. Monilial infection can also occur under the faceplate, where it can be difficult to distinguish from other forms of skin irritation.
There have been some attempts to provide an ostomy device which prevents leakage and which lasts for a longer period of time without the required maintenance. However, some of these medical devices require extensive dissection or additional operative steps in order to internally mount the ostomy ring to the patient's body. Further, currently known and available implantive type ostomy rings, require that the vessel, such as the colon, be drawn over the artificial passageway and terminate at approximately the surface of the skin. The technique of feeding the device into the vessel to provide an exterior port for the attachment of a collection pouch may cause hemorrhaging or serious infection, such as sepsis, due to irritation between the vessel and the tube and the internal leakage of fecal matter which may go into the blood stream and cause toxic sepsis.
Thus, there is a need for an ostomy appliance which can be easily adapted to currently practiced methods of performing ostomies. There is also a need for an ostomy appliance which is easily implanted into the patient's body during the ostomy procedure, and which provides the patient with an easy to use and fairly permanent port, or ostomy ring, to which a collection bag can be repeatedly attached and removed without irritation to the patient's skin or harmful and unpleasant leakage of excrement from the ostomy appliance. Further, there is a need to provide a low maintenance ostomy appliance having an internal securing or anchoring system, which utilizes the patient's naturally occurring fibrotic reaction (scar formation) to attach the ostomy ring securely to the patient's body without the need of adhesives and an exteriorly mounted faceplate.
Accordingly, it is an object of the present invention to provide an ostomy appliance which is partially implanted into the ostomy patient's body and through the patient's naturally occurring fibrosis is anchored to the body, thereby fixing the ostomy ring on the exterior of the patient's body.
It is yet another object of the present invention to provide an ostomy appliance which is readily incorporated into currently practiced enterostomy surgical procedures without requiring any additional surgical steps or additional dissection of the patient's body.
It is yet a further object of the present invention to provide a low maintenance ostomy appliance which is implanted within the patient's body, provides a fixed ostomy ring which eliminates leakage, minimizing the risk of infection and effectively reducing the amount of maintenance required by the patient.